Correspondence

ASRU operational newsletter, 12 September 2022

Published 28 September 2022

Dear all,

I am pleased to present the second instalment in a series of ASRU operational updates, which I have committed to share with members of the regulated community since taking on the role as Head of ASRU in March this year. In this communication, I hope to provide assurance and clarity on service and regulatory delivery and provide clear expectations on ASRU’s operating model and current priorities.

ASRU has recently received feedback from members of the regulated community, where concerns were raised regarding timeliness and consistency of service. My team and I want to ensure we learn from this feedback and provide clear information, guidance, and advice to help you, our regulated community, meet your responsibilities to comply. I would like to assure you that ASRU is continuing to prioritise service delivery (licensing) in accordance with our statutory obligations and compliance assurance (including audit, Standard Condition 18 report review, and enforcement) in alignment with ASPA.

This update provides a summary of our operating model and priorities and demonstrates our commitment to provide open and transparent communication on our approach to regulatory activities.

1.    Licensing

The licensing function processes licence applications and amendments which are managed through the ASPeL electronic licensing system via a “taxi rank” prioritisation process. Should you need to contact this team you can do so at ASRULicensing@homeoffice.gov.uk

The timelines for the handling of licensing tasks are shown below:

• New project application (PPL) review and any returned project application review: 40 days/55 days for complex applications

• New PPL amendment review: 40 days

• Second and subsequent PPL amendment review: 40 days

The timelines are based on the statutory requirements defined in ASPA. Our typical timelines for individual cases vary based on the complexity of the application and level of incoming applications. All days referenced are working days.

If you need to discuss an urgent PPL amendment, please contact ASRULicensing@homeoffice.gov.uk with the details.

We have received feedback that some licences seem to have been taken out of the taxi rank and actioned out of sequence. Since applications vary in complexity, they may be picked up in sequence but not necessarily completed in the same order. ASRU requests your feedback if you are concerned about your application in the taxi rank. Please contact ASRULicensing@homeoffice.gov.uk

Applications should be submitted to ASRU as early as possible to reduce the risk of delays in licensing decision and provision of licence authorities. Applications should be submitted at least four months before authority is required.

We continue to receive requests to expedite first review of applications which are submitted less than three months prior to their expiry date, and which require transfer of animals. We will not expedite any such requests unless there are exceptional circumstances. It is the responsibility of PPL holders to ensure new licences are submitted in a timely manner and to have contingency plans for animals in these cases.

PEL amendments and approved areas

We have received feedback asking for further guidance on the information required to add a new building or room to the PEL.

To amend a PEL by adding a new building or room, ASRU needs enough information to determine if the new building or room is Code of Practice compliant.

ASRU requires a sufficient understanding of a new area’s intended use to assess it for addition to the PEL. Evidence from previous inspections or audits, and appropriate supporting documentation, may be used to assess the area against the relevant PEL facility standards.

Where amendments are made to existing facilities already on the PEL, resubmission of evidence is not required. Where these sources of information prove insufficient, an on-site or remote visit may be undertaken.

On-site inspections are required for new buildings, significant refurbishments, and where the change might impact animal health or welfare. If you have further specific questions about what is required, please contact ASRULicensing@homeoffice.gov.uk.

Processing timelines

ASRU has been made aware of concerns regarding timelines for PEL amendments. ASRU’s typical timelines for licensing tasks including PEL amendments are:

• 40 working days for most PEL amendments

• 20 working days for adding/removing a named person

• 40 working days for area amendments where an on-site inspection is required.

Typical timelines for individual cases vary based on the complexity of the application and level of incoming applications. All days referenced are working days. For amendments requiring inspection, the time for individual cases may vary depending on availability of key persons at the establishment and timelines for completion of the building/room works.

If you need to discuss an urgent PEL amendment, please contact ASRULicensing@homeoffice.gov.uk with the details.

ASPeL - PPL amendments

ASRU frequently receives amendments where the applicant has underlined all new text, or used bold font, or both. Please refrain from doing this as ASPeL automatically highlights new or deleted text.

ASPeL - PIL applications

ASRU frequently receives applications for PILs where the applicant is already a PIL holder. This may lead to the creation of multiple profiles in ASPeL. We are working to insert new text on the PIL application landing page (applicant’s view) to inform applicants to transfer a licence if they already hold a PIL or revoke the PIL at the previous establishment. If you encounter difficulties, please contact ASPELTechnicalQueries@homeoffice.gov.uk

Individuals must only hold one PIL, with the exception of addition of PIL E. For example, a PIL holder may hold a PIL AB (pigs) licence but also requires PIL E for a rat microsurgery course. PIL Es are very restrictive and are held for a very short period to permit attendance at a specified training course.

Genetically altered animal (GA) protocols

The standard protocols for GA rodent and zebrafish breeding have been updated to include more refined approaches and are formatted according to the new-style ASPeL project licence application.

Revised guidance and templates have been circulated to establishments and are available on GOV.UK.

The wording provided in the guidance is suitable for all projects with standard genetically altered animal breeding and maintenance protocols - animals are not expected to die because of any authorised genetic alteration. A small number of animals, living beyond the neonatal period (5 days for mice and rats – before which ASRU does not require you to report any mortality), may suddenly and unexpectedly die having shown no preceding clinical signs indicative of impending death. Unless otherwise indicated, such deaths, should they occur, are unlikely to be related to the genotype. However, as per the published ASRU Advice Note on Severity Assessment of GA animals, should the mortality rate (age-matched) of the genetically altered strain rise beyond that present in the background source breeding colony, this should be reported under PPL standard condition 18.

To implement these changes to the GA protocols the following process will be followed:

• In new project licence applications that include breeding and maintenance of GA animals, applicants should use the new standard protocols with immediate effect.

• When project licence amendments are submitted from licences that include GA protocols, applicants should update the GA protocols in their licence.

• For new project applications and amendments already submitted, ASRU will include an additional condition with the new wording unless the application is returned with comments, in which case applicants will be asked to replace the GA protocols with the new ones.

To apply the new wording to all projects at your establishment with GA breeding and maintenance (B&M) protocols, please submit a PEL amendment. ASRU Licensing will then add a condition to the PEL that covers the wording. To support ASRU in applying these changes to licences, do not submit individual PPL amendments specifically for the purpose of including the new GA protocol wording.

For SC18 reports that are submitted for relevant non-procedural related adverse effects, ASRU will return the SC18 report with the new wording and, in order to impact all the PPLs held at the establishment, the PELh will be asked to submit a PEL amendment to enable ASRU to add the additional condition as described above.

PPL application guidance for ASPeL

We are aware this guidance has been outstanding for some time. We have been working to incorporate recent ASPeL changes and the product is now in the final stages of development. We appreciate your patience through this process and will share the final product very shortly.

2.    Compliance Assurance

The compliance assurance function delivers all activities which provide oversight and assurance to the public of licence holders’ compliance with ASPA and their licence conditions including:

• Provision of facility, systems, and thematic audits

• Monitoring of action plans for those establishments which are assessed as being at high risk of non-compliance

* Enforcement activities, through investigation and management of potential cases of non-compliance

• Reviewing reports submitted which are part of compliance assurance (e.g., SC18 reports, other reports required by a specific licence)

If you need to contact this team, please select the most appropriate mailbox from the following:

• ASRUEnforcement@homeoffice.gov.uk
• ASRUStandardCondition18@homeoffice.gov.uk
• ASRUAudit@homeoffice.gov.uk

Audit

Throughout 2022, the audit programme has continued in accordance with the inspection requirements defined by ASPA.

Audit activity for the remainder of 2022 will be focussed on:

• Facilities audits
  • To record evidence of the effectiveness of the governance systems in place to maintain compliance with Standard Conditions of the establishment licence and Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes.
  • To make decisions about any regulatory actions required to reduce risk of non-compliance. A facilities audit is an integral part of the full-systems audit approach
• Enforcement investigations
• Facility assessment for establishment licence amendment
• For-cause audits for other regulatory purposes such as investigation following a whistle-blowing report received by ASRU

Portfolios

We are aware that ASRU’s previous communications about the future requirement to provide documentation for portfolios, although intended to be helpful, have raised questions from the regulated community, particularly the potential for increased regulatory burden.

Listening to feedback received, we are reviewing our approach – we will not be taking this forward in 2022. We will use this time to refine the process and develop clear guidance and examples of evidence, along with a communication plan, which we will share in early 2023.

New Standard Condition 18 Notification and Potential Non-Compliance Notification forms

ASRU is now finalising a new SC18 notification form and accompanying guidance (previously referred to as SC18 reports). We are aware that this has been promised for a while now and we appreciate your patience as we’ve been working with our legal department to incorporate feedback from all users. As a result of this, in addition to the new SC18 notification form there will also be a separate form for you to notify us of potential non-compliance. We hope the new non-compliance notification form will make it quicker and easier for you to raise potential cases and for us to investigate. As with all our published products we will review and refine the forms once internal colleagues and you, the regulated community, have had opportunity to use and provide feedback.

POLE notification

There is now a dedicated inbox to send notifications about upcoming work at POLEs, to facilitate compliance with the additional condition on PPLs that have POLE work authorised. Please ensure the email title includes the PPL number, PPL holder’s surname and the name of the establishment.

Contacting ASRU – inboxes

Compliance assurance

Enforcement

ASRUEnforcement@homeoffice.gov.uk

 Standard Condition 18

ASRUStandardCondition18@homeoffice.gov.uk

 Audit

ASRUAudit@homeoffice.gov.uk

POLE notification

ASRUPOLEnotification@homeoffice.gov.uk

Licensing

ASRULicensing@homeoffice.gov.uk

Home Office liaison (HOLTIF) and complaints inbox

ASRUOperationalRelationshipManagement@Homeoffice.gov.uk

ASPeL Technical Queries

ASPELTechnicalQueries@homeoffice.gov.uk

Regards,

Dr Kate Chandler

Head of ASRU